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This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.
Healthy female subjects, from 11 t0 25 years old, that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks.
Thirty subjects will be randomly divided in two groups:
Group 1 will receive tretinoin cream that should be applied daily in areas affected by stretch marks.
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
Subjects will be evaluated by pictures, measurement of width and length of stretch marks, using Mirror System(Canfield).
Biopsy to quantify alterations of epidermis and dermis of treated area, will be held pre-treatment and 2 weeks after the conclusion of treatment. For biopsy will be used a punch of 3mm.
The results will be evaluated two weeks after the conclusion of the interventions. An independent dermatologist, blinded for intervention, will analyse pictures pre and post treatment. This subjective evaluation will be performed using Global Aesthetic Improvement Scale.
Safety and adverse events will be assessed each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tretinoin | Active Comparator | Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. |
|
| Superficial Dermabrasion | Active Comparator | Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tretinoin cream 0.005% | Drug | Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Width of Stretch Marks | Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) | Baseline and 16 weeks |
| Length of Stretch Marks | Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement Scale |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris M Hexsel, MD | Brazilian Center For Studies in Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazilian Center for Studies in Dermatology | Porto Alegre | Rio Grande do Sul | 90570 040 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tretinoin | Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. |
| FG001 | Superficial Dermabrasion | Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Per protocol assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | Tretinoin | Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Width of Stretch Marks | Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) | Per protocol. | Posted | Mean | Standard Deviation | centimeters | Baseline and 16 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tretinoin | Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | Itching on the treated area. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Doris Hexsel | Brazilian Center for Studies in Dermatology | +55 51 30262633 | cientifico@cbed.org.br |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Superficial Dermabrasion | Device | Group 2 will receive 16 sessions of dermabrasion that would be held in the research center |
|
| 16 weeks |
| Patient Satisfaction | Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied) | 16 weeks |
| BG001 | Superficial Dermabrasion | Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fitzpatrick skin phototype | Phototype I - Pale white skin, blue/green eyes, blond/red hair; Always burns, does not tan Phototype II - Fair skin, blue eyes; Burns easily, tans poorly Phototype III - Darker white skin; Tans after initial burn Phototype IV - Light brown skin; Burns minimally, tans easily Phototype V - Brown skin; Rarely burns, tans darkly easily Phototype VI - Dark brown or black skin; Never burns, always tans darkly | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.
Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center
|
|
| Primary | Length of Stretch Marks | Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) | Per protocol. | Posted | Mean | Standard Deviation | centimeters | Baseline and 16 weeks |
|
|
|
| Secondary | Global Aesthetic Improvement Scale |
| Per protocol. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| Secondary | Patient Satisfaction | Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied) | Per protocol. | Posted | Count of Participants | Participants | 16 weeks |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 7 |
| 10 |
| EG001 | Superficial Dermabrasion | Group 2 will receive 16 sessions of dermabrasion that would be held in the research center. Superficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center | 0 | 12 | 0 | 12 | 7 | 12 |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | Erythema on the treated area. |
|
| Scaling | Skin and subcutaneous tissue disorders | Systematic Assessment | Scaling on the treated area |
|
| Stinging | Skin and subcutaneous tissue disorders | Systematic Assessment | Stinging on the treated area |
|
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| Improved |
|
| Neither satisfied nor unsatisfied |
|